Change in HbA1c from baseline to endpoint (Week 26).

Statistical analysis of this study was performed for the full analysis set (FAS). FAS consisted of randomized patients who received administration of the study drug at least once and had measurement values after administration. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.

Percentage of subjects achieving HbA1c <=7.0% (for subjects with HbA1c >7% at baseline)

FAS Population. Only subjects with baseline HbA1c > target were included in calculation. Missing data at endpoint was imputed using LOCF approach.

Percentage of subjects achieving HbA1c <=6.5% (for subjects with HbA1c >6.5% at baseline)

FAS Population. Only subjects with baseline HbA1c > target were included in calculation. Missing data at endpoint was imputed using LOCF approach.

Change in FSG (centralized measurement) from baseline to endpoint (Week 26)

FAS Population. Missing data at endpoint was imputed using LOCF approach.

Change in Body Weight from baseline to endpoint (Week 26)

FAS Population. Missing data at endpoint was imputed using LOCF approach.

Change in Total Cholesterol from baseline to endpoint (Week 26)

FAS Population. Missing data at endpoint was imputed using LOCF approach.

Change in HDL-C from baseline to endpoint (Week 26)

FAS Population. Missing data at endpoint was imputed using LOCF approach.

Ratio of Triglycerides (measured in mg/dL) at endpoint (Week 26) to Baseline. Log(Postbaseline Triglycerides) - log(Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.

FAS Population. Missing data at endpoint was imputed using LOCF approach.

Change in Blood Pressure from baseline to endpoint (Week 26)

FAS Population. Missing data at endpoint was imputed using LOCF approach.

Major confirmed hypoglycemia was defined as (1) any event accompanying symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure but resolved promptly in response to administration of glucagon or (2) glucose, or documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) requiring assistance because of severe impairment in consciousness or motor activity whether or not symptoms of hypoglycemia were felt by the patient. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.

FAS Population.

Minor confirmed hypoglycemia was defined as any event a patient felt that he or she was experiencing a sign or symptom associated with hypoglycemia that resolved by self-treatment or on its own, and a concurrent self-monitoring fingerstick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.

FAS Population.